LEVITRA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Levitra, and what generic alternatives are available?
Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has fifty-four patent family members in thirty-one countries.
The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Levitra
A generic version of LEVITRA was approved as vardenafil hydrochloride by TEVA PHARMS on May 3rd, 2012.
Summary for LEVITRA
International Patents: | 54 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 26 |
Patent Applications: | 5,451 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LEVITRA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEVITRA |
What excipients (inactive ingredients) are in LEVITRA? | LEVITRA excipients list |
DailyMed Link: | LEVITRA at DailyMed |



Recent Clinical Trials for LEVITRA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Respira Therapeutics, Inc. | Phase 1 |
A2 Healthcare Taiwan Corporation | Phase 1/Phase 2 |
Tritech Biopharmaceuticals Co., Ltd. | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for LEVITRA
Paragraph IV (Patent) Challenges for LEVITRA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LEVITRA | Tablets | vardenafil hydrochloride | 2.5 mg | 021400 | 1 | 2009-09-04 |
LEVITRA | Tablets | vardenafil hydrochloride | 5 mg and 10 mg | 021400 | 1 | 2009-07-10 |
LEVITRA | Tablets | vardenafil hydrochloride | 20 mg | 021400 | 1 | 2009-03-05 |
US Patents and Regulatory Information for LEVITRA
LEVITRA is protected by two US patents.
Patents protecting LEVITRA
Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ERECTILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
Medicaments containing vardenafil hydrochloride trihydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-001 | Aug 19, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LEVITRA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-004 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-002 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Bayer Hlthcare | LEVITRA | vardenafil hydrochloride | TABLET;ORAL | 021400-003 | Aug 19, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEVITRA
See the table below for patents covering LEVITRA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | 228196 | 2-PHENYL SUBSTITUTED IMIDAZOTRIAZINONES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS THEREOF | ⤷ Try a Trial |
Norway | 20002444 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9924433 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |